Company Update

Transcription

Company Update

Jefferies Autumn 2015 Global Healthcare Conference
Company Update
November 18, 2015
Safe Harbor
This presentation includes forward-looking statements.
Actual results could differ materially from those included in the forward-looking statements due to
various risk factors and uncertainties including changes in business, economic competitive
conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing.
These and other risks and uncertainties are detailed in the Company’s Annual Report.
© MorphoSys AG, Company Update - November 2015
2
Broad Therapeutic Pipeline with Multiple
Near-Term Catalysts
MOR208
 Next generation Fc-enhanced antibody addressing unmet needs in B-cell malignancies
 Pivotal trial in DLBCL expected to start in 2017
Differentiated Proprietary Programs & Technologies
 Anti-CD38 antibody MOR202 for multiple myeloma in Phase 1/2
 MOR209 in Phase 1, MOR106 & MOR107 in pre-clinic
 Continued investment in technology leadership drives pipeline expansion
Pipeline Provides Strong Foundation for Growth
 Over 100 compounds in development, over 20 clinical studies to be completed by end 2016
 Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J) expected in 2016
3
The MorphoSys Pipeline
25 Clinical Product Candidates, 104 Total
Most advanced development stage
Program
Partner
Target
Disease Area
Bimagrumab (BYM338)
Guselkumab (CNTO1959)
Gantenerumab
MOR208
MOR103/GSK3196165
MOR202
BHQ880
CNTO3157
CNTO6785
LFG316
LJM716
BPS804
Tarextumab (OMP-59R5)
VAY736
MOR209/ES414
Anetumab Ravtansine (BAY94-9343)
BAY1093884
BI–836845
NOV–7
NOV–8
NOV-9
NOV-10
NOV-11
PF-05082566
Vantictumab (OMP-18R5)
MOR106
MOR107 (LP2)
Immuno-oncology program
Immuno-oncology program
6 MOR programs
Novartis
Janssen
Roche
GSK
Novartis
Janssen
Janssen
Novartis
Novartis
Mereo/Novartis
OncoMed
Novartis
Emergent
Bayer
Bayer
BI
Novartis
Novartis
Novartis
Novartis
Novartis
Pfizer
OncoMed
Galapagos
Merck Serono
Immatics
-
ActRIIB
IL23p19
Amyloid-ß
CD19
GM-CSF
CD38
DKK-1
C5
HER3
Sclerostin
Notch 2
BAFF-R
PSMA/CD3
Mesothelin (ADC)
TFPI
IGF-1
4-1BB
Fzd 7
AT2-R
-
sIBM (musculoskeletal)
Psoriasis
Alzheimer’s disease
ALL, CLL, NHL
Inflammation
Multiple myeloma
Multiple myeloma
Inflammation
Inflammation
Eye diseases
Cancer
Brittle bone syndrome
Solid tumors
Inflammation
Prostate cancer
Solid tumors
Hemophilia
Solid tumors
Eye diseases
Inflammation
Diabetic eye diseases
Cancer
Blood disorders
Solid tumors
Solid tumors
Inflammation
Fibrosis
Cancer
Cancer
Various
Discovery
Preclinic
Phase 1
Phase 2
Phase 3
90 Partnered Programs
13 MOR Programs
1 Outlicensed Program
In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery
4
The MOR Portfolio
Program
Indication
Target
Discovery Preclinic Phase 1
Phase 2
Phase 3
Unpartnered
MOR208
NHL
CLL
FTD, orphan status US & EU
CD19
Orphan status US & EU
ALL
MOR202
Multiple myeloma
CD38
MOR107
Fibrosis
AT2-R
Immuno-oncology
program
(Immatics)
Cancer
Various
6 Programs
Various
Various
Co-development & co-promotion
MOR209/ES414
(Emergent)
MOR106
(Galapagos)
Immuno-oncology
program
(Merck Serono)
Prostate cancer
PSMA / CD3
Inflammation
Undisclosed
Cancer
Undisclosed
5
MOR208
First- & Best-in Class Potential
 Fc-enhanced, humanized IgG1 antibody targeting CD19
 CD19 is target of choice for B-cell malignancies
 CD20 down-regulated after anti-CD20 treatment
 CD19 down-regulation not described
 Fc modification leads to dramatically enhanced B cell
depletion
 antibody dependent cellular cytotoxicity (ADCC)
 phagocytosis
 direct cytotoxicity
 Convenient dosing schedule, straightforward manufacturing
 Strong pre-clinical support for combo therapy
6
MOR208
Superior to Other CD19 & CD20 MAbs in R/R CLL
Response Rates Based on IWCLL2008 Criteria
anti-CD19 MAbs
anti-CD20 MAbs
SD, PD & non-evaluable
ORR
38%
MOR208
12mg/kg
(n=16)
mPFS
14
(months)
MEDI-551 data source: Poster
ASCO 2013, 12mg/kg dosing
group
24%
30%
MEDI-551
phase 1/2
12mg/kg
(n=26)
Obinutuzumab
phase 2
(n=20)
Ofatumumab
phase 3
(n=196)
Rituximab
(n=110)
NR
10.7
8
5.5
23%
13%
Obinutuzumab data source:
GAUGUIN study, Cartron et al,
Blood 2014
Ofatumumab data source:
control arm in ibrutinib vs. O
phase 3 trial (RESONATE,
ASCO 2014)
Rituximab data source: Late
breaking abstract #6, ASH
2013
Criteria: Hallek et al 2008
(including CT)
[NR – not reported]
7
MOR208
Strong Single Agent Efficacy in R/R NHL
Best overall response*
n (%)
DLBCL
n=35
FL
n=34
Other iNHL
n=11†
MCL
n=12
Total
n=92
Complete response
2 (6%)
3 (9%)
2 (18%)
0
6 (7%)
Partial response
7 (20%)
6 (18%)
1 (9%)
0
15 (16%)
Stable disease
5 (14%)
17 (50%)
4 (36%)
6 (50%)
32 (35%)
Progressive disease
11 (31%)
4 (12%)
3 (27%)
5 (42%)
23 (25%)
Not evaluable‡
10 (29%)
4 (12%)
1 (9%)
1 (8%)
16 (17%)
ORR (CR + PR)
9 (26%)
9 (26%)
3 (27%)
0
21 (23%)
ORR (Evaluable pts)
9 (36%)
9 (30%)
3 (30%)
0
21 (31%)
*Investigator assessed
†iNHL cohort not expanded due to heterogeneity
‡Post-baseline response assessment not performed/data unavailable
CR, complete response; ORR, objective response rate
Jurczak et al, #1528, ASH 2015
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MOR208
Comprehensive Clinical Development Plan
Indication
NHL
2015
2016
2017
2018
MOR208 (12 mg/kg); N=92
DLBCL
MOR208 (12mg/kg) + lenalidomide; 2nd line R/R; N=80
Safety evaluation leading into anticipated pivotal study
MOR208 (12 mg/kg) + bendamustine; 2nd line R/R; N~320
CLL
MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120
MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation; N=50 (Ohio State Univ. IIT)
ALL
MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude’s IIT)
Phase 2
Phase 2/3
IIT: Investigator-initiated trial
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MOR208
Significant Unmet Medical Need
MOR208 addresses shortcomings in current
B cell cancer treatment options
 CD20 down-regulation
 Patients unable to manage side effects of TKIs
 TKI relapses: very unfavourable prognosis,
median survival 3-4 months in CLL
Incidence / Deaths (USA, 2015)
30.000
25.000
20.000
Major medical need in DLBCL and CLL
 DLBCL: Ca. 40% treated with chemoimmunotherapy/ASCT eventually relapse,
becoming refractory to current agents*
 CLL: Patients who are discontinued after BTKi
treatment relapse very quickly and have a
very poor prognosis
15.000
10.000
5.000
0
DLBCL
New Cases
CLL
Deaths
* Mounier et al. Best Pract Res Clin Haematol. 2012
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MOR202
A Novel Antibody for Multiple Myeloma
 HuCAL IgG1 antibody binding unique epitope
on CD38
 One of only three CD38 antibodies in clinic
 Potent ADCC and ADCP
 Full killing of MM cells
 Low killing of healthy/effector cells
 Strongly synergistic with IMiDs and proteasome
inhibitors in pre-clinical models
 Best-in-class infusion tolerability as consistent
2-hour infusion
11
MOR202
Encouraging Activity in Ongoing Phase 1/2a Study
Data from patients in cohorts ≥ 4 mg/kg weekly MOR202 + Dex
who received > 1 treatment cycle
S: serum; U: urine.
30% ORR seen so far (study not completed yet)
Raab et al., IMW 2015
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MOR202
Clinical Development Plan
Indication
2015
2016
2017
2018
MOR202 monotherapy, dose escalation &
confirmation cohorts; N~62*
Multiple
myeloma
MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24**
MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24*
MOR202 combo study to be based on Phase 2
Phase 2
Phase 2/3
* Patients who have failed at least 2 prior therapies
** Patients who have failed at least 1 prior therapy
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MOR202
Increasing Interest in Antibodies in MM
Multiple myeloma (MM) treatment: a large commercial opportunity
 Leading therapies already generate over $5.0bn in worldwide sales
 Estimated to reach $10.2bn by 2020
 Biologics to generate $8bn by 2023 mostly from anti-CD38 Mabs
MM is a growing market
 Increasing adoption of new agents
in 1st line setting & maintenance
 Use of targeted agents in combo
regimens
CD38 is an Ideal Target for
Hematologic Diseases
 Opportunities beyond MM based on
CD38 expression
14
MOR209/ES414
A Novel Bi-specific Antibody for Prostate Cancer
 Bi-specific ADAPTIR antibody targeting
 PSMA on prostate cancer cells, levels increase with progression
 CD3 on cytotoxic T cells
 Compelling pre-clinical data
 Encouraging activity in vitro and in vivo
 Less cytokine release on T cell activation in pre-clinical models
compared to other formats
 Prolonged half-life in mouse and NHP compared to other
formats
Indication
2015
2016
2017
2018
MOR209/ES414: Phase 1/2 dose escalation (N~50)
mCRPC*
MOR209/ES414: Phase 1/2 dose extension (N~80)
Phase 3 preparations
Phase 1/2a
Phase 3
* Metastatic castration-resistant prostate cancer
15
Clinical Programs Pursued by Partners (I)
Program
Bimagrumab
(BYM338)
Partner
Novartis
Target
ActRIIB
Guselkumab
(CNTO1959)
Janssen/J&J
IL23p19
Gantenerumab
Roche
Amyloid-ß
BHQ880
Novartis
DKK-1
BPS804
Mereo/Novartis
Sclerostin
CNTO3157
Janssen/J&J
n.d.
CNTO6785
Janssen/J&J
n.d.
LFG316
Novartis
C5
LJM716
Novartis
HER3
Indication
Phase 1
sIBM (52 weeks)
sIBM (extension)
sIBM (long-term study)
Hip fracture surgery
Sarcopenia
Psoriasis (VOYAGE 1)
Psoriasis (NAVIGATE)
Pustular/Erythrodermic Psoriasis
Moderate to severe psoriasis
Active psoriatic arthritis
Mild Alzheimer‘s disease
Prodromal Alzheimer‘s disease
Genetically predisposed
MM (renal insufficiency)
Smoldering MM
Osteoporosis
Hypophosphatasia (HPP)
Osteogenesis Imperfecta
Asthma
Safety/Pharmacokinetic
COPD
Rheumatoid arthritis
Age-related AMD
Geographic atrophy
Panuveitis
Paroxysmal nocturnal hemoglobinuria
ESCC (combo with BYL719)
HER2+ cancer (combo BYL719 & trastuzumab)
HER2+ cancer, combo with trastuzumab
Phase 2
Phase 3
Partnered discovery programs
16
Clinical Programs Pursued by Partners (II)
Program
Partner
Target
MOR103/GSK3196165 GlaxoSmithKline GM-CSF
Tarextumab
Oncomed/GSK
Notch 2
(OMP-59R5)
Indication
Phase 1
Rheumatoid Arthritis
Pancreatic cancer (ALPINE)
Small cell lung cancer (Pinnacle)
Solid tumors
BAY1093884
Bayer
TFPI
Bleeding disorders
BAY94-9343
Bayer
Mesothelin Solid tumors
Anetumab Ravtansine
Advanced malignancies (Japan)
BI-836845
BI
IGF-1
Solid tumors, Japanese patients
EGFR mutant NSCLC
Breast cancer
CRPC + enzalutamide
Various solid cancer
Advanced solid tumors
NOV-7
Novartis
n.d.
Eye disease
NOV-8
Novartis
n.d.
Inflammation
NOV-9
Novartis
n.d.
Diabetic eye disease
NOV-10
Novartis
n.d.
Cancer
NOV-11
Novartis
n.d.
Blood disorders
PF-05082566
Pfizer
4-1BB
Solid tumors, NHL (+rituximab)
Solid tumors, combo with PD-1i MK-3475
Advanced solid tumors, with mogamulizumab
Advanced malignancies, with avelumab
VAY736
Novartis
BAFF-R
Pemphigus vulgaris
Primary Sjögren‘s syndrome
Primary Sjögren‘s syndrome
Vantictumab
Oncomed/Bayer Fzd 7
Solid tumors
(OMP-18R5)
Breast cancer
Pancreatic cancer
NSCL
Phase 2
Phase 3
Out-licensed program
Partnered discovery programs
17
MOR103/GSK3196165
Anti-inflammatory Program Licensed to GSK
MOR103/GSK3196165
 HuCAL antibody specific for GM-CSF
 GM-CSF is important in every step of macrophage
production and infiltration in the tissues
Indications
 Lead indication: Rheumatoid arthritis (RA)
 Potential for disease modification & analgesic activity in
hand osteoarthritis (HOA)
Current Status
 BAROQUE (RA phase 2b) ongoing
 Initial clinical read-out 2016
 Phase 2 in hand osteoarthritis to start in 2016
GM-CSF plays a key role in
activation of macrophages at the
site of injury or inflammation
18
MOR103/GSK3196165
Promising Clinical Data in RA
 Phase 1b/2a study in RA patients
 Good magnitude of effect with fast onset of action and long
duration post treatment
 Effect size appears similar to or greater than anti-TNF
 Targeting the macrophage in early RA
 Potential for early use to induce remission
19
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
Bimagrumab
 HuCAL antibody specific for ActRIIB, antagonizes
myostatin binding
 Lead indication: sporadic inclusion body myositis (sIBM)
 FDA breakthrough therapy designation
 Orphan drug designation
Current Status
 Pivotal study in sIBM with 240 patients ongoing,
completion scheduled for Q4 2015
 Phase 3 data expected in H1 2016
 Listed by Novartis as “planned filing 2016”
 Phase 2 read-outs in sarcopenia expected in 2016
M. Schuelke at al, N Engl J Med 2004;350:2682-8
20
Bimagrumab (BYM338)
Promising Phase 2 Data in sIBM*
 Bimagrumab, single dose, 30 mg/kg
 Muscle mass increased approx. 5% more than placebo
 Muscle gain was functional
 Increases in strength parallel to physical performance and in 6-minute walking distance
Data courtesy of Novartis
[*] A Amato et al; Neurology; Nov 7, 2014, online
[1] Statistically significant difference
21
A Janssen Anti-Inflammatory Program
Guselkumab
 A HuCAL antibody specific for IL-23, does not bind IL-12
 IL-23 blockade inhibits production of multiple cytokines
beyond IL-17A and preserves Th1 & Treg regulatory pathways
 Being developed in psoriasis and psoriatic arthritis
Current Status
 Five Phase 3 clinical trials ongoing
 First Phase 3 data expected in 2016
 Anticipated filing in 2016
Source: Jetten AM, Nucl Recept Signal, 2009
22
Clinical Data
 Highest levels of durable skin clearance with less intensive dosing regimens vs. anti-IL-17 class
 Potential for similar safety profile vs. long-term blockade of IL-12 + 23 with STELARA®
 Potential for long-term, drug-free efficacy
Data courtesy of Janssen
23
PHASE 2
PHASE 3
Clinical Trials Scheduled for Completion
Guselkumab
Bimagrumab
sIBM
Guselkumab
Guselkumab
Psoriasis (NAVIGATE)
CNTO6785
Rheumatoid arthritis
MOR202
Multiple myeloma
√
Bimagrumab
Sarcopenia
CNTO6785
COPD
MOR208
NHL (mono - update)
√
LFG316
Panuveitis
LJM716
ESCC, combo w/BYL719
LFG316
Age-related AMD
MOR208 - IST
CLL (combo with len)
LFG316
PNH
Tarextumab
Pancreatic cancer
PHASE 1
BI-836845
BAY94-9343
Solid tumors
Tarextumab
Solid tumors
LJM716
LJM716
HER2+ cancer (combo)
√
BI-836845
NSCLC
MOR209
Prostate cancer
Vantictumab
NSCLC
BI-836845
Solid tumors (Japan)
Vantictumab
Breast cancer
Vantictumab
Pancreatic cancer
BI-836845
Various solid cancer
Vantictumab
Solid tumors
√
2015
Potential data events based on clinical trial design & MorphoSys estimates
2016
Partnered Discovery Programs
MOR Programs
24
Powerful Technology Base Ensures Pipeline
Sustainability
Innovative Targets
Proprietary Platforms
GPCRs, ion channels
Antibody library
Immune checkpoints
Protein optimization
MHC-presented,
tumour-associated
peptides
Differentiated
drug candidates
Lantipeptides
25
Financial Guidance 2015
2014A
9M 2015
Guidance 2015
Group Revenues
64.0
93.9
101 to 106
Proprietary R&D Expenses
(incl. Technology Development)
36.4
39.9
56 to 63
EBIT
-5.9
34.7
9 to 16
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial
assets
352.8
317.7
in € million
26
What to Expect?
Updated data from phase 2 mono-therapy trial at ASH 2015
DLBCL: Phase 2 lenalidomide combo trial to start in Q4 2015
Phase 3 bendamustine combo trial expected to start in 2017
MOR208
CLL:
Phase 2 idelalisib combo trial to start in Q1 2016
ALL:
Phase 2 pediatric IIT with NK cell transfusion to start in H1 2016
MOR202
Updated data from phase 1/2a trial at ASH 2015
MOR209
First phase 1 data expected in 2016
Bimagrumab
Guselkumab
Pipeline
Data from pivotal trial in sporadic inclusion body myositis expected early 2016
Filing expected in 2016
Data from 3 pivotal trials in psoriasis expected 2016
Filing expected in 2016
MOR106 & MOR107 to start clinical development in 2016
Potential in-licensing of additional compounds
27
Thank You
www.morphosys.com
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-122
Fax
+49 (0)89 / 899 27-5122
Email [email protected]
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® , Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.

Company Update

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